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Ultrablator
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref ESA-5373Ref ESA-5379Ref ESA-5296Ref ESA-5336Ref ESA-5333Ref ESA-5236Ref ESA-5339
Identity
- Trade Name
- ULTRABLATOR EUDAMEDFDA UDI
- Generic Name
- Endoscopic electrosurgical electrode, monopolar, single-use FDA UDI
- Device Name
- Orthopedic, Active, Instrument, Electrosurgical, Monopolar, Electrode EUDAMEDULTRABLATOR 30°, THREE RIB, 110 MM LENGTH, 3.2 MM DIAMETER FDA UDIULTRABLATOR 30°, 110 MM LENGTH, 2.5 MM DIAMETER FDA UDIULTRABLATOR 90°, THREE RIB, 130 MM LENGTH, 3.2 MM DIAMETER FDA UDIULTRABLATOR 90°, THREE RIB, 110 MM LENGTH, 3.2 MM DIAMETER FDA UDIULTRABLATOR 30°, THREE RIB, 130 MM LENGTH, 3.2 MM DIAMETER FDA UDIULTRABLATOR 90°, 110 MM LENGTH, 2.5 MM DIAMETER FDA UDIULTRABLATOR 30°, 110 MM LENGTH, 3.2 MM DIAMETER FDA UDI
- Model / Reference
- ESA-5373 EUDAMEDFDA UDIESA-5379 EUDAMEDFDA UDIESA-5296 EUDAMEDFDA UDIESA-5336 EUDAMEDFDA UDIESA-5333 EUDAMEDFDA UDIESA-5236 EUDAMEDFDA UDIESA-5339 EUDAMEDFDA UDI
- Description
- ULTRABLATOR 30°, THREE RIB, 110 MM LENGTH, 3.2 MM DIAMETER FDA UDIULTRABLATOR 30°, 110 MM LENGTH, 2.5 MM DIAMETER FDA UDIULTRABLATOR 90°, THREE RIB, 130 MM LENGTH, 3.2 MM DIAMETER FDA UDIULTRABLATOR 90°, THREE RIB, 110 MM LENGTH, 3.2 MM DIAMETER FDA UDIULTRABLATOR 30°, THREE RIB, 130 MM LENGTH, 3.2 MM DIAMETER FDA UDIULTRABLATOR 90°, 110 MM LENGTH, 2.5 MM DIAMETER FDA UDIULTRABLATOR 30°, 110 MM LENGTH, 3.2 MM DIAMETER FDA UDI
Identifiers
- Catalog Number
- ESA-5333 FDA UDIESA-5236 FDA UDIESA-5379 FDA UDIESA-5339 FDA UDIESA-5373 FDA UDIESA-5296 FDA UDIESA-5336 FDA UDI
- Primary DI / UDI-DI
- 10845854029572 EUDAMEDFDA UDI10845854029589 EUDAMEDFDA UDI10845854029558 EUDAMEDFDA UDI10845854029565 EUDAMEDFDA UDI10845854020609 EUDAMEDFDA UDI10845854029541 EUDAMEDFDA UDI10845854020616 EUDAMEDFDA UDI
- Basic UDI-DI
- B-10845854029572 EUDAMEDB-10845854029589 EUDAMEDB-10845854029558 EUDAMEDB-10845854029565 EUDAMEDB-10845854020609 EUDAMEDB-10845854029541 EUDAMEDB-10845854020616 EUDAMED
- 510(k) Number
- K030720 FDA UDI
- FDA Product Code
- GEI FDA UDI
- EMDN Code
- K02030101 RADIOFREQUENCY SURGERY ELECTRODES, SINGLE-USE EUDAMED
- GMDN Term
- Endoscopic electrosurgical electrode, monopolar, single-use FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 878.4400 FDA UDI
- Market of Registration
- Belgium EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Angle — 30 degree FDA UDIOuter Diameter — 3.2 Millimeter FDA UDILength — 110 Millimeter FDA UDIOuter Diameter — 2.5 Millimeter FDA UDILength — 130 Millimeter FDA UDIAngle — 90 degree FDA UDI
Ultrablator by Conmed Corporation — Class IIb — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-10845854029572 | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- Manufacturer
- Conmed Corporation
- EUDAMED SRN
- US-MF-000012663
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (21)
- EUDAMED a818e0f9-534d-4871-a043-025fd2b225ae 61 fields · synced Jul 15, 2026
- EUDAMED 57774577-3acb-41b0-89c4-85c021bc4d85 61 fields · synced May 16, 2026
- EUDAMED 45b5e2f8-cb2a-4564-81a4-92432b9ac0b5 61 fields · synced May 16, 2026
- EUDAMED 41508d3f-fa35-421a-baee-90e2f7009e79 61 fields · synced May 16, 2026
- EUDAMED e7bd0fcb-179b-4961-96ce-d433e5bca54f 61 fields · synced May 16, 2026
- EUDAMED 194651dc-7d0e-4c44-9bf3-2a4a81a3ffce 61 fields · synced May 17, 2026
- EUDAMED 76a85f8e-f32c-40e4-befb-2089bc0cc973 61 fields · synced May 19, 2026
- FDA UDI 9040d307-f295-4491-a555-5af19a01556d 37 fields · synced May 29, 2026
- FDA UDI 6f5d0c84-4706-41e4-8cbe-b4faea4044a3 37 fields · synced May 30, 2026
- FDA UDI 3a47219b-f920-41d7-8816-373aaffc347f 37 fields · synced May 30, 2026
- FDA UDI f035cd40-336a-4780-b530-8c58fee20adc 37 fields · synced May 30, 2026
- FDA UDI 1f8d876f-b392-42eb-a108-dfb0d24a0ec6 37 fields · synced May 30, 2026
- FDA UDI 303f58fa-7b59-4d80-a330-0c5cb55577b4 37 fields · synced May 30, 2026
- FDA UDI 9c087d4d-9aad-493e-8baa-94072bd7f66a 37 fields · synced May 30, 2026
- EUDAMED 6305cb04-0f89-4a24-8efd-09f4ba2837bb 61 fields · synced Jun 20, 2026
- EUDAMED e9ccec4e-5aa7-4e8c-96b0-e08130f88887 61 fields · synced Jul 9, 2026
- EUDAMED c9ea5f2e-ebc4-4617-9a73-51b9da9addb0 61 fields · synced Jul 11, 2026
- EUDAMED c764e8f5-35f9-4373-a1c2-bec4f77dbcb0 61 fields · synced Jul 11, 2026
- EUDAMED e0f7273c-c637-47a4-b6dd-97d632c0beb1 61 fields · synced Jul 14, 2026
- EUDAMED 0865f39e-8cb0-4720-baef-8a26f623f823 61 fields · synced Jul 14, 2026
- EUDAMED 57e9b370-72a2-4269-a74b-add9d917fd42 61 fields · synced Jul 15, 2026